Current medical research and opinion
-
Objective: The aim of this study was to provide recommendations for improving the design of subsequent studies through analysis of the registered coronavirus disease 2019 (COVID-19) clinical trials. Methods: A retrospective analysis of 189 trial retrievals achieved on 20 February 2020. Results: A total of 189 trials are included in the study. ⋯ Study design characteristics: 71% of all studies were randomized, 5% of all studies were blinded, 18% of all studies were multicenter and 76% of all studies were single center. Conclusion: Although many COVID-19 studies include randomization in their design, the lack of additional double-blind and placebo-controlled elements in their designs result in a less robust evaluation of intervention safety and efficacy. Furthermore, similar or repeated research and small sample studies that have less promise in gains of new information have possibly led to a shortage of recruitable patients and become a barrier to the completion of large multicenter clinical trial studies.
-
Randomized Controlled Trial Multicenter Study
Efficacy and safety of DBPR108 monotherapy in patients with type 2 diabetes: a 12-week, randomized, double-blind, placebo-controlled, phase II clinical trial.
Objective: DBPR108, a novel dipeptidyl-peptidase-4 inhibitor, has shown great antihyperglycemic effect in animal models. This study was to evaluate the efficacy and safety of DBPR108 monotherapy in type 2 diabetes mellitus (T2DM). Methods: This was a 12-week, double-blind, placebo-controlled phase II clinical trial. ⋯ At end of 12-week treatment, the goal of HbA1c ≤7% was achieved in 29.85, 58.82, 55.22, and 47.83% of the patients in placebo, 50, 100, and 200 mg DBPR108 groups, respectively. The incidence of adverse events did not show significant difference between DBPR108 and placebo except mild hypoglycemia in DBPR108 200 mg group. Conclusions: The study results support DBPR108 100 mg once daily as the primary dosing regimen for T2DM patients in phase III development program.
-
Cardiac arrhythmias are the most common cardiac complication reported in pregnant women with and without structural heart disease (SHD); they are more frequent among women with SHD, such as cardiomyopathy and congenital heart disease (CHD). While older studies had indicated supraventricular tachycardia as the most common tachyarrhythmia in pregnancy, more recent data indicate an increase in the frequency of arrhythmias, with atrial fibrillation (AF) emerging as the most frequent arrhythmia in pregnancy, attributed to an increase in maternal age, cardiovascular risk factors and CHD in pregnancy. Importantly, the presence of any tachyarrhythmia during pregnancy may be associated with adverse maternal and fetal outcomes, including death. ⋯ Regarding the anticoagulation regimen in patients with AF, warfarin should be substituted with heparin during the first trimester, while direct oral anticoagulants are not indicated given the lack of data in pregnancy. Finally, for refractory arrhythmias, ablation and/or device implantation can be performed with current techniques in pregnant women, when needed, using minimal exposure to radiation. All these issues and relevant current guidelines are herein reviewed.